![]() ![]() ![]() In the context of clinical studies, fair allocation is best characterized as equity. The precise definition of fairness in allocation is determined by the context. Some situations require an equal distribution (for example, one person, one vote), while others call for an equitable distribution (such as from each according to ability, to each according to need). It is impossible to arrive at a precise general definition of fair allocation, however, because the criteria for fairness may differ from one context to another. Clinical studies, especially those in the earliest stages where safety or toxicity is being measured, often involve substantial risks to human subjects. Of these conceptions of justice, the most widely applicable to human subjects research is distributive justice. An example from the history of human subjects research is that of monetary payments made to survivors of the Tuskegee syphilis study or to their relatives, to compensate them for the harm or wrong done by the study. The notion of compensatory justice goes beyond that of fairness in distribution in an attempt to remedy or redress past wrongs. For example, procedural justice applies to a wide variety of social, legal, and institutional matters in which achieving a fair or unbiased result is dependent on adherence to a set of well-ordered procedures, such as the legal requirements of due process. Other conceptions of justice may apply in differing situations. The conception of justice embodied in the Belmont Report is essentially that of distributive justice, a notion pertinent to situations that call for the fair allocation of society's benefits and burdens. These subjects were deprived of demonstrably effective treatment in order not to interrupt the project, long after such treatment became available. In this country, in the 1940s, the Tuskegee syphilis study used disadvantaged, rural black men to study the untreated course of a disease that is by no means confined to that population. Subsequently, the exploitation of unwilling prisoners as research subjects in Nazi concentration camps was condemned as a particularly flagrant injustice. In sketching the historical background related to justice in research, its report cited the following examples of injustices:ĭuring the 19th and early 20th centuries the burdens of serving as research subjects fell largely upon poor ward patients, while the benefits of improved medical care flowed primarily to private patients. The Belmont Report states that "injustice arises from social, racial, sexual and cultural biases institutionalized in society." Women as a class were not the primary concern of the National Commission's work. Justice, the third of these basic principles, is the main focus of this chapter.Beneficence is understood as the obligation to maximize possible benefits and minimize possible harms in conducting research.Respect for persons reflects two basic convictions: "first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection.".In that document, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission) outlined three ethical principles that should govern research: ![]() Concerns about justice in the conduct of biomedical research involving human subjects received little attention until the publication of the Belmont Report (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1978). ![]()
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